The law and medicine management

1. The Law & Medicine Management
Return to Professional Practice
Siân Shaw: Senior Lecturer
Anglia Ruskin University: January 2015

2. Medicines licensing
! Pharmaceutical Companies need to apply for a license
for use to either Medicines and Healthcare Products
Regulatory Agency (MHRA) for a UK License
! Or European Medicines Agency (EMA) for an EU
License
! Pharmaceutical Companies invest heavily in
researching and developing new drugs

3. Medicines Act 1968
Case Study
! Initiated by the thalidomide tragedy of
1950’s and 1960’s.
! The drug was marketed as a mild sleeping
pill safe even for pregnant women
! Developed in 1950’s by West German
pharmaceutical company Grunenthal.
! Over 10,000 children born with
thalidomide related disabilities.
! Made if compulsory for all Medicines to be
licensed before they could be introduced to
the UK market.

4. Case Study Continued
! How do you think that the thalidomide tragedy
affected drug prescribing in pregnancy?
! What is the nurse’s / midwives role in advising
pregnant women on what drugs they can safely take?

5. Medicines Act (1968) and (1971) and
amended directions (2000)
! There are three categories of drugs for public use:
! P (pharmacy medicines) are those that can only be sold
under the supervision of a pharmacist in a registered
premises. These are medicines you would buy at a
chemist without a GP prescription, but they cannot be
sold in a supermarket or shop.
! GSL (general sales list) are those medicines that can be
sold without supervision.
! POM (Prescription only medicines) are those that are sold
in accordance with a prescription from an authorised
prescriber)

6. Evidence Based Practice and
Research
! Using a copy of the British National Formulary or
accessing the online version (http://bnf.org.bnf).
Categorise the medicines listed below.
! Paracetamol
! Vitamin C
! Gaviscon liquid
! Voltarol gel
! Imigran tablets
! Codeine
! Co-codamol
! Penicillin
! Diazepam

7. Evidence Based Practice and
Research
! Using a copy of the British National Formulary or
accessing the online version (http://bnf.org.bnf).
Categorise the medicines listed below.
! Paracetamol
! Vitamin C
! Gaviscon liquid
! Voltarol gel
! Imigran tablets
! Codeine
! Co-codamol
! Penicillin
! Diazepam

8. Accountability
! Jim is a registered nurse and is undertaking the
medicines round. She checks Mrs. Jones’ medicines,
places them in a medicine pot and because she is not in
her bed leaves them on her bedside locker to take on her
return. He makes a mental note to return to check they
have been taken. Jim become distracted nu another
patient ; he locks the medicines trolley and attends to the
patient. In the meantime Mrs. Davies in the next bed to
Mrs. Jones has dementia and ingests Mrs. Jones’
medicines. When Mrs. Jones returns she asks Jim for her
medicines, the pot is found to be empty.
! Imagine you are in Jim’s position. Who might ask you to
explain what you did in regard to this incident?

9. NMC Sanctions from Pubic Hearings
! Nurse given a suspension order for one year for failing
to demonstrate knowledge and skill in relation to
insulin administration.
! A Nurse who failed to check a patient’s name banc or
complete the drug round was given a caution for 3
years

10. Consent
! All nurses must gain consent before any interventions ,
and medicines administration is included.
! Competent patients have the right to self-
determination.
! Every person is presumed to have capacity to consent
unless it is proven otherwise (Re T Adult Refusal of
Treatment [1932] 3 WLR
! A person lacking capacity to consent can be treated in
their best interests F v West Berkshire Health
Authority [1990]

11. Accountability and the NMC
! The nursing and Midwifery Order 2001 established the
NMC in 2002
! The NMC’s Primary purpose is to ensure that the
registrants provide a high quality of safe care.
! Promotes standards in publications e.g. the Code,
! Provides advice and considers allegations of
misconduct.

12. Accountability to your employer
! Civil law- vicarious liability. An employer accepts the liability for any acts their
staff may commit. This is on the proviso that the practitioner has practiced in
accordance with the trust policy and guidance and within the law.
! Nurses have a professional duty to notify their employer if they feel the trust
does not meet legal requirements.
! Employer has a right to instigate its own disciplinary process if a nurse makes
a mistake, but consideration of the nurse’s honesty and actions to mimimise
further harm to the patient will be a factor in the decision made.
! If a nurse is dismissed , then under the Employment Act 2002 they have the
right t appeal.
! Patients do in certain circumstances choose to make a claim against individual
nurses.

13. Professional Accountability
! Accountability towards fellow nurses / midwives
! If a nurse finds a colleague misusing drugs , for
example, they they have a legal obligation and
professional duty to report this to their manager.
! Should the manager fail to act upon the information
provided by the concerned nurse than the Public
Interest Disclosure Act 1999 protects the nurse from
victimisation should they wish to disclose this further.

14. Reliance
! Jane is the staff nurse on Ward 21. While working on a
night shift she says that she administered Mr.
Thomas’s antibiotics at 10pm and when she checked
on him at midnight he was fast asleep. At 2am Mr.
Thomas is found unresponsive by another staff nurse
and is subsequently admitted to the intensive care unit
following and anaphylactic reaction. When the family
are informed about the incident they are very angry
and accuse Jane of being negligent.

15. Negligence
! If a patient suffers harm as a result of negligence by
either the prescriber or the administrator – then the
patient or next of kin can bring an action.
! For example is a patient is prescribed and
administered a drug without any explanation of what
the drug is for, and it the patient suffers side effects
that cause home, the law on consent may be
important as it could be argued that the patient did
not provided valid consent

16. Negligence
! If a patient suffers harm as a result of negligence by
either the prescriber or the administrator – then the
patient or next of kin can bring an action.
! For example is a patient is prescribed and
administered a drug without any explanation of what
the drug is for, and it the patient suffers side effects
that cause home, the law on consent may be
important as it could be argued that the patient did
not provided valid consent

17. Proving Negligence
(Definition Anderson B in Blyth V
Birmingham Waterworks (1856)
11EXCH 781
! The defendant owed a duty of care to the person
harmed
! That they breached that duty
! That the breach cause was foreseeable (Causation)
! That there was harm caused to the claimant

18. Duty of Care
! Nurse have a ‘duty of care’
which means that they
must act in the best
interests of their patients,
acknowledge their
limitations in relation to
both knowledge and skill ,
and ensure that no act or
omission of theirs should
be injurious to patients.
! Duty of care was defined by
Lord Atkin in Donoghue v
Stephenson (House of
Lords) (1932) cited in NMC
2008.

19. Bolam v Friern Hospital Management
Committee [1957] 1 W.L.R 582
! The Bolam case set the precedent that has become
known as the Bolam test that identifies the standard of
care that practitioners can be measured against.
! Judge McNair
! the standard of the ordinary skilled man exercising an
professing to have that skill.. It is sufficient if he exercises
the ordinary skill of an ordinary competent man
exercising a particular act. {a doctor] is no guilty of
negligence if e has acted in accordance with a practice
accepted as proper by a responsible body of medical med
skilled in that particular art.

20. Duty and Breach
! Nurses have a duty of care to their patients.
! In considering whether their was a breach of that duty
the judge would seek advice from nurse experts and
utilise Standards for medicines management document
as well as any local policies to determine what was
reasonabel and an acceptable standards as set out in
the Bolam test.

21. Causation
! Causation can be complex to prove
! Kay v Ayreshire and Arran Health Board [1978 2 All 417
! Wilsher v Essex Health Authority CA. 1986 ALL, ER 801
HL 1988 1 ALL ER871

22. Record Keeping
! Your documentation is your defense,

23. Harm
! Crushing medicines
! Usually in the best interests of the patient
! It can potentially alter the therapeutic properties of a
drug
! A patient could be harmed as a results
! Consult with the prescriber or pharmacist before crushing
to see if the drug can be given in a different format.

24. Defenses to a claim in negligence
1. Denial of the facts: the defense claims that they were not to
blame: remember the burden of proof is with the claimant.
2. Missing elements: one or more of the four elements (duty,
breach, causation and harm) are missing.
3. Volenti Non Fit Injuria (to a willing person, no injury is
done): an example would be people engaged in contact sports
such as boxing or judo who give their consent to fight as are
well aware do the risks – they would not consent to being hit
by anyone in any other circumstances.
4. Contributory negligence: the claimant still has some liability
and the damages awarded can be reduced. An example would
be not wearing a seatbelt and claiming for personal injury in a
car crash.

25. Limitation Act
! A claimant has only a limited time span in which to
bring a claim
! Rules are laid out in the Limitation Act 1980
! In cases of personal injury it is limited to three years
! There are exception in cases of mental incapacity and
children.
! Midwives are at the greatest risk of NHS negligence
claims

26. Criminal Law
! Mens rea – mental element of the crime
! Actus rea – the act itself
! If a patient is harmed as a result of an error relating to
medicines management and if this harm is extreme and the
patient dies as a consequence of such an error, then as a nurse
or midwife you could face a criminal charge for gross negligence
which could lead to a charge of manslaughter or even murder.
! Case: Beverly Allitt: Killed 4 children in 3 months with lethal
doses of insulin. It was the diligence of 2 paediaticians who were
concerned about the the number of cardiac arrest on one of
their wards that led to the investigation and subsequent
conviction.

27. Controlled Drugs
! Harold Shipman convicted in January 200 of the
murders of 15 of his patients.
! He told them he was giving then vitamin injections, in
reality he administered lethal doses of morphine.
! As a consequence of this, each hospital trust must now
have an accountable officer whose role it is to take
responsibility for the safe use of controlled drugs.

28. Medicines Management in Children
! The Family Law Reform Act 1969 Sec 8(1) allows children who have
attained 16 years of age to consent on their won behalf for surgical,
medical or dental treatment including the administration of an
anaesthetic.
! Gillack Competence: Mrs Gillack was concerned that allowing under
16’s to gain advice with our parental consent might encourage a
criminal offence under the Sexual Offences Act of 1967 (which was
replaced in 2003 by the current Act)
! To be Gillack Competent a child under 16 can give their own consent
which is fully legally valid is they have the intellectual, emotional
and maturity as well as the ability to understand what the proposed
treatments.
! Fraser Guidelines: specifically relate to contraceptive advice to the
under 16’s.